Alkermes, Cephalon gain preliminary approval for Vivitrol from FDA

By Ted A. Knutson

Washington, Dec. 28 - Alkermes, Inc. and Cephalon, Inc. announced Wednesday the Food and Drug Administration issued an approvable letter for Vivitrol (naltrexone for extended-release injectable suspension), which is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support.

Alkermes and Cephalon continue to prepare for the launch of the drug during the second quarter of 2006.

"This approvable letter is a positive step toward the approval of Vivitrol," stated Richard Pops, chief executive officer of Alkermes, in a press release. "We look forward to working diligently with the FDA to gain final approval and bring forward Vivitrol as an important new medication for the treatment of alcohol dependence."

Alkermes is a Cambridge, Mass.-based pharmaceutical company.

Cephalon is a Fraser, Pa.-based biotechnology company.

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